Pulmonary EmbolismPhase 3RESCUENCT04248868
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
A Phase 3 study testing The Bashir™ Endovascular Catheter and r-tPA in people with Pulmonary Embolism, run by Thrombolex, Inc. at 19 sites in United States.
Trial summary
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- The Bashir™ Endovascular Catheter and r-tPA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 19 sitesUnited States
- Study dates
- 23 Jun 2020to 23 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent;
- Age 18 to ≤ 75 years of age;
- PE symptom duration ≤ 14 days.
- Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
- RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
- Willing and able to comply with all study procedures and follow-up.
Who cannot join
- CVA or TIA within one (1) year;
- Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diatheses;
- Hematocrit < 30%;
Show all 31Show fewer
- Platelets < 100,000/μL;
- INR > 1.5 if currently on warfarin (Coumadin®);
- aPTT > 50 seconds in the absence of anticoagulants;
- Major surgery ≤ 14 days prior to inclusion in the study;
- Serum creatinine > 2.0mg/dL;
- Clinician deems high-risk for catastrophic bleeding;
- History of heparin-induced thrombocytopenia (HIT Syndrome);
- Pregnancy;
- SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
- Any vasopressor support;
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- Evidence of irreversible neurological compromise;
- Life expectancy < one (1) year;
- Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
- Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) within 48 hours prior to inclusion in the study;
- Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- Previous enrollment in this study;
- Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
- BMI > 45kg/m2;
- Absolute contraindication to anticoagulation;
- Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
- Currently participating in another study;
- Any arterial line placement;
- Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or > 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
- In the opinion of the investigator, the subject is not a suitable candidate for the study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Emory
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
CAMC
Charleston, West Virginia, 25304
Mt Carmel
Columbus, Ohio, 43213
Ascension St. John Hospital
Detroit, Michigan, 48201
UPMC Hamot
Erie, Pennsylvania, 16550
Ascension St. Vincent
Indianapolis, Indiana, 46260
Tennova Heart - Turkey Creek
Knoxville, Tennessee, 37934
St. Joseph's Hospital
Liverpool, New York, 13088
UCLA
Los Angeles, California, 90095
Loyola University Chicago
Maywood, Illinois, 60521
Miami Cardiac & Vascular Institute
Miami, Florida, 33176
University of Minnesota
Minneapolis, Minnesota, 55455
NYU Langone
New York, New York, 10016
Advent Health Orlando
Orlando, Florida, 32803
Temple University Hospital
Philadelphia, Pennsylvania, 19122
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15232
NC Heart
Raleigh, North Carolina, 27607
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
Read the detailed description
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter directed thrombolysis in patients with submassive PE who have consented and meet all eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).
The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.
- Conditions
- Pulmonary Embolism
- Being tested
- The Bashir™ Endovascular Catheter, r-tPA
- Keywords
- Pulmonary Embolism, Catheter Directed Therapy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Bashir™ Endovascular CatheterDevice
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
r-tPADrug
Pulse spray and infusion
| Study group | Role | What they receive |
|---|---|---|
| BEC Treatment | Experimental | The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. Receives: Device: The Bashir™ Endovascular Catheter; Drug: r-tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: RV/LV Ratio Difference
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Measured: 48 hours after the completion of r-tPA treatment
Safety: Major Bleeding
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients
- Fatal bleeding; and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or
- Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
Measured: Within 72 hours of initiation of r-tPA administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start23 Jun 2020
- Primary completion22 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pulse Spray and Infusion of r-tPA
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thrombolex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Brian Firth, MD, PhD, MBA, FACC, Principal investigator, Thrombolex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248868
- Sponsor's protocol ID
- THRO-CLIN-2019-01
- Acronym
- RESCUE
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2020
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bashir R, Foster M, Iskander A, Darki A, Jaber W, Rali PM, Lakhter V, Gandhi R, Klein A, Bhatheja R, Ross C, Natarajan K, Nanjundappa A, Angle JF, Ouriel K, Amoroso NE, Firth BG, Comerota AJ, Piazza G, Rosenfield K, Sista AK. Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2427-2436. doi: 10.1016/j.jcin.2022.09.011. Epub 2022 Sep 17.
PubMed 36121244
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
- ClinicalTrials.gov ID
- NCT04248868
- Acronym / sponsor ID
- RESCUE / THRO-CLIN-2019-01
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Catheter Directed Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Thrombolex, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
Detailed description
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter directed thrombolysis in patients with submassive PE who have consented and meet all eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).
The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pulse Spray and Infusion of r-tPA
| Arm | Type | Receives |
|---|---|---|
| BEC Treatment | Experimental | Device: The Bashir™ Endovascular Catheter, Drug: r-tPAThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide informed consent;
- Age 18 to ≤ 75 years of age;
- PE symptom duration ≤ 14 days.
- Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
- RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
Key exclusion criteria (31 listed)
- CVA or TIA within one (1) year;
- Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- Patients with bleeding diatheses;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Bashir™ Endovascular CatheterThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. | Device | BEC Treatment |
| r-tPAPulse spray and infusion | Drug | BEC Treatment |
Primary outcome
Efficacy: RV/LV Ratio Difference
Time frame: 48 hours after the completion of r-tPA treatment
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Safety: Major Bleeding
Time frame: Within 72 hours of initiation of r-tPA administration
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36121244Bashir R, Foster M, Iskander A, Darki A, Jaber W, Rali PM, Lakhter V, Gandhi R, Klein A, Bhatheja R, Ross C, Natarajan K, Nanjundappa A, Angle JF, Ouriel K, Amoroso NE, Firth BG, Comerota AJ, Piazza G, Rosenfield K, Sista AK. Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2427-2436. doi: 10.1016/j.jcin.2022.09.011. Epub 2022 Sep 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Firth, MD, PhD, MBA, FACC principal investigator
Thrombolex, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The Bashir™ Endovascular Catheter and r-tPA in people with Pulmonary Embolism, run by Thrombolex, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: RV/LV Ratio Difference (time frame: 48 hours after the completion of r-tPA treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.